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首页> 外文期刊>European journal of pharmaceutics and biopharmaceutics: official journal of Arbeitsgemeinschaft fuer Pharmazeutische Verfahrenstechnik e.V >Online monitoring of dissolution tests using dedicated potentiometric sensors in biorelevant media.
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Online monitoring of dissolution tests using dedicated potentiometric sensors in biorelevant media.

机译：在生物相关介质中使用专用电位传感器在线监测溶出度测试。

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摘要

The performance of the Ion-Selective Electrode (ISE) for in vitro dissolution testing using biorelevant media was evaluated in this study. In vitro dissolution was carried out using USP apparatus 2 (paddle method) with classical and with updated biorelevant media to simulate the pre- and postprandial states. The ISE was used as an analytical stand-alone system and in combination with a single-point HPLC-UV measurement. A modified method enabling the use of the ISE for very poorly soluble substances is also proposed. In terms of f(2)-factor, the results acquired using the ISE for the drug diphenhydramine-HCl were found to be very similar to the results obtained by manual sampling followed by HPLC-UV analysis. In Fed State Simulated Gastric Fluid (FeSSGF), a medium containing 50% milk, the ISE is more practical since the need to separate proteins from the analyte prior to HPLC-UV analysis is eliminated. Further work will be needed to establish ISE methodology for Fed State Simulated Intestinal Fluid (FeSSIF) media. In summary, the ISE has promise as an analytical tool for research and development applications.
机译：在这项研究中，对使用生物相关介质进行体外溶出度测试的离子选择电极（ISE）的性能进行了评估。使用USP装置2（桨式法）在体外进行溶出，并使用经典方法和更新的生物相关培养基模拟餐前和餐后状态。 ISE被用作独立的分析系统，并与单点HPLC-UV测量结合使用。还提出了一种改进的方法，该方法允许将ISE用于难溶性极强的物质。在f（2）因子方面，发现使用ISE获得的药物苯海拉明-HCl的结果与通过手动采样随后进行HPLC-UV分析获得的结果非常相似。在含有50％牛奶的培养基联邦模拟胃液（FeSSGF）中，ISE更加实用，因为消除了在进行HPLC-UV分析之前从分析物中分离蛋白质的需要。将需要进一步的工作来建立用于美联储状态模拟肠液（FeSSIF）介质的ISE方法。总而言之，ISE有望作为研究和开发应用程序的分析工具。

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